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Documentation for Validation in pharmaceutical filling and capping machine

Created on:2024-05-11

 

Quality might be an ambiguous concept if you cannot prove it while comparing it to clearly defined standards. In RELIANCE MACHINERY we take quality very seriously and never get exhausted of giving evidence of it. Our packaging machines are built from scratch with prime quality materials and complete with state of-the-art technology. We uniquely code every single component, keep full track of it, and provide documentation certifying its compliance with Pharmaceutical industry regulations. Get to know our comprehensive range of certificates to grasp what prime quality means to us.

 

 

Documentation provided by Reliance Machinery for Validation:


An essential list ready for you includes for instance: certificates of all materials and parts in contact with the product, welding certificates, calibration certificates, and parts full traceability.

The provision goes beyond the latter certificates for proving the component's quality and compliance, as it stretches to further documents concerning the line construction and effectiveness. The list goes on with IQ (Installation qualification), OQ (Operational Qualification), PQ (Performance Qualification), FDS (Functional design specifics), HDS (Hardware design specifics), and Risk analysis.

 

 


 

 

FDA Regulations:


As fundamental parts of the safety measures in the pharmaceutical industry, security systems to govern access and recorded data on the production line can also be provided. They can manage different levels of access (e.g. operator, factory, administration) making the machinery compliant with CFR 21 part 11 regulation.

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